Class Claims Skin Cream Could Cause Tumors
LOS ANGELES (CN) - An Allergan skin cream contains human growth factors derived from human foreskin that could increase the risk of tumors, a class action claims in Federal Court.
Named plaintiff Josette Ruhnke sued Allergan and its subsidiary SkinMedica for unfair competition, consumer law violations and false advertising.
She claims the defendants misbranded and unlawfully marketed a line of "cosmeceutical" skin care products under the name Tissue Nutrient System (TNS), by failing to disclose safety concerns and failing to get government approval.
The term "cosmeceutical" conveys that the products - including items such as eye repair, moisturizer and body lotion - are both cosmetic and pharmaceutical, the complaint states.
The TNS products, which are pushed for skin rejuvenation, contain a proprietary mix of human growth factors "derived from human foreskin tissue," according to the complaint.
Human growth factors are intended to mobilize, stimulate, decrease, or otherwise alter the production of cells. "Importantly, they had the ability to initiate cell division (cell division)," the complaint states.
"The human growth factors contained in TNS products pose significant health risks, including but not limited to the risk of cancer. Indeed, growth factors are believed to contribute to the growth of tumor cells or other abnormalities," Ruhnke says in the complaint.
SkinMedica does not adequately disclose these safety concerns, but "describes growth factors in the Product Guide as proteins that 'regulate cellular growth and the activity of skin cells.' SkinMedica further describes TNS, a Tissue Nutrient Solution, as 'a combination of growth factors and other naturally occurring elements that are crucial to the regeneration of healthy skin,'" the complaint states.
SkinMedica also fails to disclose that the products cannot legally be sold in California and the United States, the complaint states.
Neither the FDA nor the California Department of Public Health has determined that the products are safe or approved them for sale, Ruhnke says.
She claims that TNS products are drugs under federal and state law because they use human growth factors to affect the structure and function of the skin through cell division, multiplication and regeneration of skin tissue.
"SkinMedica wrongly pronounces that TNS products do not require FDA approval. Because TNS products are drug products being sold without FDA approval, and because SkinMedica does not provide mandatory and important product labeling information (as required by the FDA and California DPH for such products), they are misbranded." (Parentheses in complaint.)
Ruhnke seeks punitive damages and wants the defendants enjoined from selling the products without full disclosure of safety concerns and without government approvals.
She is represented by Lee M. Gordon.
Allegan acquired SkinMedica in December 2012, according to the complaint, which does not explain how they acquire human foreskin tissue.